Merz Aesthetics Announces FDA Approval of Xeomin (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines

RALEIGH, NC – July 23, 2024 -- Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the U.S. Food and Drug Administration (FDA) approved Xeomin (incobotulinumtoxinA) as the first and only neurotoxin for the simultaneous treatment of upper facial lines – forehead lines, frown lines and crow’s feet.

First approved in 2011, Xeomin was indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines. This new upper facial lines FDA approval adds the indication for the treatment of horizontal forehead lines and lateral canthal lines, or crow’s feet, in addition to the previous frown lines indication.

“Xeomin is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines, frown lines and crow’s feet lines),” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “This new indication for Xeomin proves we are moving the needle within the toxin space and meeting the needs of our consumers as it comes to efficacy and results, while containing only the essential ingredients needed for treatment.”

Xeomin is now indicated for the temporary improvement in the appearance of moderate to severe upper facial lines. The total recommended Xeomin dose for treatment is 20 units for glabellar frown lines, 20 units for horizontal forehead lines and 24 units for the crow’s feet for a total of 64 units.

“Unlike other toxin treatments, we filter out all of the unnecessary ingredients in Xeomin using proprietary XTRACT Technology™, so we’re left with only the ingredients essential for treatment, which 90% of surveyed patients say they absolutely want in a neurotoxin treatment,” said Patrick Urban, President, North America, Merz Aesthetics. “We’re so excited to hit this significant milestone for Merz Aesthetics as we continue to expand our ‘Beauty on Your Terms’ campaign and footprint within the aesthetics industry.”

In fact, unnecessary proteins found in some other toxin formulations may cause an immune response which can lead to a decreased effect and failure of treatment. In a recent survey, just over 1 in 3 toxin users reported to have experienced decreased, or lessening effects, of toxin treatments. The double filtration and removal of unnecessary proteins of Xeomin, also referred to as SmartTox, makes it less likely to lead to lessening or limiting results. The formulation minimizes the risk and offers a consistent experience across the new versatile indication.

The new indication comes on the coattails of the brand’s recent partnership with Demi Lovato and the continuation of the Merz Aesthetics multi-channel, digital-first ‘Beauty on Your Terms’ campaign. First launched in August 2022, the campaign was developed to introduce Xeomin to a younger, adult audience that is new to the injectables category and to empower them to embrace beauty on their own terms.

“In my opinion and experience, Xeomin is the smart choice for treatment of my upper facial lines,” said Demi Lovato, Xeomin brand partner. “The SmartTox formula is double filtered with only the ingredients essential for treatment to give me natural-looking results treatment after treatment.”

The approval for treatment of upper facial lines stems from clinical studies demonstrating the simultaneous treatment efficacy and safety of Xeomin. The phase three double-blind, placebo-controlled studies included 730 adult participants randomized to receive Xeomin or placebo. Both studies met their primary endpoints with Xeomin having a significantly higher response rate than placebo at Day 30 for all upper facial line areas. Results showed the simultaneous treatment of upper facial lines with Xeomin was well tolerated: all treatment-related adverse events were mild to moderate, and no treatment-related serious adverse events were observed. The unique formulation of Xeomin without unnecessary proteins had an excellent performance profile. Study data showed high patient satisfaction and continued efficacy over 14 months of multiple treatment cycles.

To learn more about Xeomin and locate a provider near you, visit XeominAesthetic.com where you can access the Find a Provider tool. You can also sign up for the Xperience+ Loyalty Program at xperiencemerz.com to receive instant and future rewards on Xeomin and additional Merz Aesthetics® treatments at your preferred practice.

Follow @XeominAesthetic on Instagram to stay up to speed on the latest news.

About Merz AestheticsMerz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 110 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 52 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at US.MerzAesthetics.com.

About Xeomin (incobotulinumtoxinA)Xeomin (incobotulinumtoxinA) is a botulinum toxin type A and the first and only neurotoxin approved by the U.S. Food and Drug Administration (FDA) for the simultaneous treatment of upper facial lines – forehead lines, frown lines and crow’s feet. Xeomin is indicated for the temporary improvement in the appearance of moderate to severe upper facial lines. For more information, including Full Prescribing Information and Medication Guide, please visit www.xeominaesthetic.com. See below for Important Consumer Safety Information.

Head-to-head studies evaluating the relative risk of immunogenicity due to the presence or absence of complexing/unnecessary proteins have not been performed.

Xeomin (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive.

To learn more:

Talk to your health care provider or pharmacist

Visit www.xeominaesthetic.com to obtain the Full Prescribing Information and Medication Guide

Call 1-866-862-1211

Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe upper facial lines (frown lines, forehead lines, and crow’s feet) in adults for a short period of time (temporary). Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com.

Warnings: XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:

Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.

People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.

Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.

Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Do not use XEOMIN if you are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:.

have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)

have had any side effect from any other botulinum toxin in the past

have a breathing problem such as asthma or emphysema

have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)

have bleeding problems

have drooping eyelids

have plans to have surgery

have had surgery on your face

are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.

Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past. Especially tell your doctor if you

have received any other botulinum toxin product in the last four months

have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.

have recently received an antibiotic by injection

take muscle relaxants

take an allergy or cold medicine

take a sleep medicine

Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Possible Side Effects

XEOMIN can cause serious side effects that can be life threatening including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint. See “Warnings.”

The most common side effect of XEOMIN in people with upper facial lines include:

injection site bruising

These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

General information about the safe and effective use of XEOMINMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

Active Ingredient: botulinum toxin type A

Inactive Ingredients: human albumin and sucrose

Xeomin (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive.

To learn more:

Talk to your health care provider or pharmacist

Visit www.xeominaesthetic.com to obtain the FDA-approved product labeling

Call 1-866-862-1211

Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It is not known if XEOMIN is safe and effective in children under 18 years of age. Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com.

People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)

have had any side effect from any other botulinum toxin in the past

have a breathing problem such as asthma or emphysema

have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)

have bleeding problems

have drooping eyelids

have plans to have surgery

have had surgery on your face

are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

have received any other botulinum toxin product in the last four months

have recently received an antibiotic by injection

take muscle relaxants

take an allergy or cold medicine

take a sleep medicine

Possible Side Effects

The most common side effect of XEOMIN in people with frown lines include:

headache

These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

Active Ingredient: botulinum toxin type A

Inactive Ingredients: human albumin and sucrose

Please see Xeomin full Prescribing Information including BOXED WARNING and Medication Guide.

Source: Merz Aesthetics

Posted : 2024-07-24 07:15

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Merz Aesthetics Announces FDA Approval of Xeomin (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines

Read more

Disclaimer

Popular Keywords